Remote Regulatory Submissions Specialist – EU IVDR/CE

Mira; Greater London; À distance; GBP 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote work

OKR bonus

Career growth

Résumé du poste

Mira is seeking a Regulatory Submission Specialist to lead and support the preparation, review and submission of regulatory documentation for in vitro diagnostic devices. You will ensure clinical, analytical, usability, risk-management, quality, and labelling evidence is compiled into submission-ready documentation, supporting regulatory compliance throughout the product lifecycle.

The ideal candidate has experience in regulatory submissions, technical documentation and international IVD

Qualifications

• Bachelor degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or related discipline.
• 2+ years of experience in regulatory affairs for medical devices or in vitro diagnostic devices, including technical documentation/submissions.
• Experience supporting CE-marking under EU IVDR (Reg. EU 2017/746).
• Knowledge of IVD quality/regulatory frameworks: ISO 13485, ISO 14971, ISO 20916; post-market surveillance.
• Experience reviewing analytical/clinical-performance documentation for IVDs; familiarity with CLSI EP guidelines.

Responsabilités

• Prepare, compile, and maintain IVD regulatory submission dossiers and technical documentation.
• Review intended-use statements, product claims, instructions for use, labelling and product specs for regulatory alignment.
• Assess analytical, clinical-performance, usability, stability, software, and risk-management evidence to support claims.
• Coordinate evidence collection from internal teams, manufacturers, CROs, labs, quality teams, external consultants.
• Identify evidence gaps and develop regulatory plans for analytical/clinical performance studies.

Connaissances

Technical writing

Project management

Stakeholder coordination

Independent work

Formation

Bachelor degree in Regulatory Affairs or related

Description du poste

Mira is seeking a Regulatory Submission Specialist to lead and support the preparation, review and submission of regulatory documentation for in vitro diagnostic devices. You will ensure clinical, analytical, usability, risk-management, quality, and labelling evidence is compiled into submission-ready documentation, supporting regulatory compliance throughout the product lifecycle.

The ideal candidate has experience in regulatory submissions, technical documentation and international IVD